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Severe infections or trauma to the endometrial lining causes permanent scars that disrupt the menstrual cycle and lead to conceive failure. Transplantation of biological graft seeded with stem cells is purposed to regenerate and recover the capability of the endometrial lining back into its cycles. Initially, the techniques to isolate and culture the endometrial cells and amnion epithelial stem cells were developed, then the endometrial cells form patients with thin endometrium. Tissue were obtained from hysteroscopic biopsy, weight between 100 µl, while up to 20 µl from the thin endometrium. Tissue were digested using collagenase-1 and cultured using DMEM-F12 added wit epidermal growth factor. Endometrial cells will be characterized to SSUD2, ICAM and BRCP1. Amnion epithelial stem cells (hAESC) will be isolated using collagenase-1 and hyaluronidase. Characterization towards TRA-1-60, SSEA-4, Oct 3/4, and Nanog. In the future, the cells will be co-culture on amnion bilayer, and stained using IHC against α-cadherin, estrogen receptor α, progesterone receptor. Endometrial receptivity (HOXA10, LIF (early secretory) adhesion, VEGF, osteopontin (SPP1) to indicate the pinopodes will be identified using qPCR.The SPP1, target of MIR424 expressed during the receptive phase.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Amnion only | Sham Comparator | Amnion bilayer as a scaffold to overlay the endometrium, with minor curettage prior to stick the scaffold. |
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| Amnion- self endometrium stem cells (EnSC) | Experimental | Amnion bilayer as a scaffold, seeded with endometrium stem cells to regenerate the thin endometrium. |
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| Amnion- amnion epithelial stem cells (AESC) | Experimental | Amnion bilayer as a scaffold, seeded with amnion epithelial stem cells to regenerate the thin endometrium. |
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| Amnion- co culture self EnSC - AESC | Experimental | Amnion bilayer as a scaffold, seeded with co-culture of endometrium stem cells and amnion epithelial stem cells to regenerate the thin endometrium. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Amnion only | Biological | Patients endometrium will be transplanted with amnion only (without seeded cells) |
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| Measure | Description | Time Frame |
|---|---|---|
| Change in endometrium thickness | Observation by USG | 7 and 14 days after amnion bilayer seeded with endometrial cells co-cultured with hAESC is transplanted into patient' womb |
| Change in amenorrhea severity | Patients' report | 7 and 14 days after amnion bilayer seeded with endometrial cells co-cultured with hAESC is transplanted into patient' womb |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Achmad Kemal Harzif, MD | Contact | +62 813-1586-6390 | kemal.achmad@gmail.com | |
| Normalina Sandora, PhD | Contact | +62 812-9896-3425 | normalinasandora@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Achmad Kemal Harzif, MD | Faculty of Medicine, Indonesia University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| RSUPN Cipto Mangunkusumo | Recruiting | Jakarta Pusat | DKI Jakarta | 10430 | Indonesia |
| Type | Date | Date Unknown |
|---|---|---|
| Release | Nov 29, 2024 | |
| Reset | Jan 17, 2025 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Nov 29, 2024 | Jan 17, 2025 |
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None of the participants, gynecologists, statistician, nurses nor of the participant' partners are informed about the treatment groups.
| Amnion - endometrium cells | Biological | Patients endometrium will be transplanted with amnion seeded with endometrium cells isolated from the patients themselves |
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| Amnion - amnion epithelial cells | Biological | Patients endometrium will be transplanted with amnion seeded with amnion epithelial stem cells isolated from other patients' caesarean sectio amnion membrane (tested HLA-DR negative to prevent rejection) |
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| Amnion-EnSC-AESC | Biological | Patients endometrium will be transplanted with amnion seeded with endometrium cells-amnion epithelial stem cells co-culture |
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